drugset / Trial / NCT01471379
Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
RandomizedParallel-groupDouble-blindTreatment
Summary
Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for treating irritable bowel syndrome (IBS) in women. Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS. Procedures: This study will observe patients treated with Savella® as well as patients treated with a placebo (pill with no active drug). The investigators will monitor and compare several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Savella® improves clinical pain response as well as secondary outcomes including quality of life.
Timeline
- Start
- 2012-04
- Primary completion
- 2013-02
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Milnacipran | Other / unclassified | 50 mg | Oral |
| Comparator | Milnacipran | Other / unclassified | 100 mg | Oral |